BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2800103 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02662
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ABNORMAL SHUTDOWNS) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR HAD INTERMITTENT COMMUNICATION FAULTS WITH PROCESSOR U104. THE CAUSE FOR THE COMMUNICATION FAULTS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A FRACTURED BGA SOLDER JOINT. THE ROOT CAUSE OF THE FRACTURED SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE STRESS ON THE MONITOR C/A BOARD. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U104 COMPONENT. THE PATIENT WAS FITTED WITH A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6), FEMALE, PATIENT, CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT SEVERAL ABNORMAL SHUTDOWNS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR